Safety and Tolerability Study of an Edible Colon Preparation

January 26, 2018 updated by: ColonaryConcepts LLC

An Adaptive, Single-Blind, Parallel, Randomized, Phase 2, Formulation Screening/Proof of Concept, Safety, Tolerability and Efficacy Study of Three Formulations/Dosing Regimens of ECP (PEG 3350) Colon Prep Kit Compared to Comparators.

The purpose of this study is to learn about a new bowel preparation that uses food to clean the colon.

In order to learn about this new food preparation, some people in this study will get the food preparation, and others will get the standard liquid bowel preparation.

Patients will be randomized (like flipping a coin) to one of five groups:

Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this Phase 2 formulation screening/proof of concept study is to evaluate the safety, tolerability, and efficacy of up to 3 ECP-019 formulations/dosing regimens comprising a PEG 3350 Colon Prep Kit, containing electrolytes provided by the foods, in 3 formulations/ dosing regimens as compared to 2 comparators in a Phase 2 study.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46290
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients whose physician has prescribed colonoscopy for colorectal cancer screening or surveillance for colorectal cancer.
  • Patients with a previous history of completing a bowel cleansing procedure for a colonoscopy.

Exclusion Criteria:

  • Known intestinal stricture of any etiology.
  • History of diabetes mellitus.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECP-019 A (Group A)
Drug: ECP-019
Experimental: ECP-019 B (Group B)
Drug: ECP-019
Experimental: ECP-019 C (Group C)
Drug: ECP-019
Active Comparator: Group D
Drug: MoviPrep® (PEG 3350)
Active Comparator: Group E
Drug: NuLYTELY® (PEG 3350)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale.
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients who completed each of the ECP-019 formulation/dosing regimens
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ColonaryConcepts LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECP-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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